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A Randomised Clinical Investigation to Assess Efficacy of Low Volume Transanal Irrigation by Qufora® IrriSedo MiniGo Versus Conservative Treatment for Low Anterior Resection Syndrome Patients

Recruitingn/aAges 18 Years - anyAllQufora A/S
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In plain words

What the trial is, and whether it could suit you

The purpose of this post-market clinical follow up study is to assess the efficacy on clinical symptoms of LARS of low volume Transanal Irrigation by MiniGo in conjunction with conservative treatment versus conservative treatment at 3 months.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Adult aged from 18 years 2. Patients electively treated for rectal cancer with a low anterior resection 3. Between 3 and 18 months after the conservative colorectal surgery or 3 and 18 months after the stoma reversal if applicable 4. LARS score \>= 25 (minor or major LARS) (Emmertsen and Laurberg 2012) AND LARS definition as consensus with at least one symptom that results in at least one consequence (Keane et al. 2020) 5. Adult for whom previous conservative treatments were started for at least a month 6. Mental and physical capability of the patient to handle the MiniGo by himself. 7. Check of the anastomosis (no signs of leakage or clinical relevant stenosis) and absence of local recurrence by Rectal digital examination of the anastomosis, any other exam used in the current practice 8. Patient affiliated to the health social security system Exclusion Criteria: 1. Contra-indication to use TAI 2. Former use of TAI (post colo-rectal surgery) 3. Clinically relevant stenosis 4. Current metastatic disease or local recurrence 5. Ongoing chemotherapy 6. Postoperative radiotherapy for rectal cancer 7. History of diarrhoeal disease 8. Inflammatory bowel disease 9. Dementia 10. Spinal cord injury, multiple sclerosis, Parkinson's disease or other significant disease assessed to be a contributory cause to LARS symptoms. 11. Patient with cancer recurrence 12. Patient with a life expectancy \< 1 year 13. Participating to another clinical trial for the treatment of LARS symptom 14. Ongoing pelvic floor rehabilitation/biofeedback 15. Pregnancy or intention to become pregnant during the trial period 16. Inability and unwillingness to give informed consent
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What it tests

  • Not listed
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Where

9 sites
CHU Amiens-Picardie
Amiens, France
CHU Besançon
Besançon, France
Clinique Tivoli-Ducos
Bordeaux, France
CHU Grenoble
La Tronche, France
CHU Timone
Marseille, France
CHU de NANTES, Hôtel Dieu
Nantes, France
CHU Bordeaux, GH Sud, Hôpital HAUT-LEVEQUE
Pessac, France
CH Lyon Sud
Pierre-Bénite, France

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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